Press Releases

Date Title
May 2, 2024
Outlook Therapeutics® to Present at the Retina World Congress 2024
ISELIN, N.J. , May 02, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at
April 29, 2024
Outlook Therapeutics® to Present at the Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase
ISELIN, N.J. , April 29, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced it will present at
April 15, 2024
Outlook Therapeutics® Announces Closing of Private Placement of $5.0 Million
ISELIN, N.J. , April 15, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed
March 22, 2024
Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD
Positive opinion serves as a basis for final decision for potential authorization from the European Commission (EC), expected within 67 days ISELIN, N.J. , March 22, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval
March 18, 2024
Outlook Therapeutics® Announces Closing of Private Placement of up to $159 Million
ISELIN, N.J. , March 18, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed
March 12, 2024
Outlook Therapeutics® Announces Effective Date for 1-for-20 Reverse Stock Split
ISELIN, N.J. , March 12, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the “Company”), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that a 1-for-20 reverse
February 14, 2024
Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update
NORSE EIGHT underway with first subject dosed and additional clinical sites beginning enrollment Continue to expect planned resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024 Anticipate review decision from European regulators in the first half of CY2024 ISELIN,
January 31, 2024
Outlook Therapeutics® Doses First Subject in NORSE EIGHT
NORSE EIGHT clinical trial is being conducted under Special Protocol Assessment (SPA) from FDA to support expected resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024, if successful ISELIN, N.J. , Jan. 31, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc.
January 23, 2024
Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010
Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010 NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024 Private placements to top tier
December 22, 2023
Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU
Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024 Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application (MAA) decision date anticipated in the first half of 2024 Resubmission of the ONS-5010 Biologics
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